Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
ConditionProstate Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40+
SponsorUniversity of Washington
About this trial
This study investigates ways to detect prostate cancer earlier in people at genetic risk for disease that forms, grows, or spreads quickly (aggressive). Studying samples of blood, urine, and/or tissue in the laboratory may help doctors further understand the genetics of prostate cancer and help identify ways to detect cancer earlier, thereby improving treatment and methods of early detection in the future.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
People with prostates ≥40 years of age
Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.
Disqualifiers
Prior diagnosis of prostate cancer
Medical contraindication to any of the study procedures (e.g., prostate biopsy)
For all cancer types except non-melanoma skin cancer, any cancer treatment with curative intent within the past 12 months (e.g., surgery, radiation, chemotherapy, immunotherapy)
Prior or concurrent participation in an interventional clinical trial aimed at preventing cancer for people with germline variants associated with increased prostate cancer risk
Trial population
Germline carriers of pathogenic or likely pathogenic mutations in genes associated with increased risk of prostate cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood, urine, and/or tissue samples
Laboratory Biomarker Analysis
Other interventionCorrelative studies
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
450 Participants
are divided into 1 treatment groupGroup A: Screening (biospecimen collection)4 interventions
Trial outcomes
Primary outcomes
1
Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds
To estimate PPVs of age-based PSA thresholds for biopsy referral in this patient population, will first fit a logistic regression model to estimate the odds that biopsy leads to a prostate cancer diagnosis. The regression will have a binary indicator of prostate cancer diagnosis as the response variable, patient age at biopsy (categorized as \< 50, 50-59, or \>= 60 years to correspond to the age-based PSA thresholds) as a fixed effect, and a unique patient identifier as a random effect to account for possibly repeated biopsies. Will then convert the estimated odds that biopsy leads to a prostate cancer diagnosis within each age category into corresponding probabilities of this outcome-i.e., PPV point estimates and associated 95% confidence intervals-using the inverse logit function.
Time frame
Up to 10 yearsSponsors and contacts
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University of Washington
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Canary Foundation
Collaborator
CureBRCA
Collaborator
Source ClinicalTrials.gov